FDA.report

KARL STORZ SCB

Primary DI
04048551062265
Brand
KARL STORZ SCB
Company
Karl Storz GmbH & Co. KG
Model
20097020-1
Device description
KARL STORZ OR1 control
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
ODAendoscopic central control unit

Product Code Classifications

CodeDeviceSpecialtyClass
ODAEndoscopic Central Control UnitGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04048551062265PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04048551062265040485510622654048551062265

GMDN Terms

TermDefinition
Operating room audiovisual data/device management systemA mains electricity (AC-powered) device assembly designed to provide operating room (OR) staff with a single point of management to operate electromechanical/electronic medical devices of different makes during surgery. It is a computer-based integrated hardware/software application that typically consists of a base unit (outside the sterile field or the OR) to which all device cabling is connected, and software that runs on an off-the-shelf computer with a touchscreen (in the OR). The system is intended to manipulate devices such as OR lights, OR tables, cameras, video endoscope images, and monitors; it may also be used to manage patient data from these devices.

Sterilization Methods

Method

Regulatory Flags

DUNS number
315731430
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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